CORONET 100— 510(k) K913785
Substantially EquivalentMicro-Shev , Ltd.
FDA 510(k) clearance K913785 for CORONET 100, Substantially Equivalent on 1991-12-31. Applicant: Micro-Shev , Ltd.. Device class: 2.
Clearance details
- Applicant
- Micro-Shev , Ltd.
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Efrat, IL
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